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Thử nghiệm lâm sàng ngẫu nhiên có đối chứng tiến cứu×Giai đoạn III Thử nghiệm lâm sàng×
Lĩnh vựcDịch tễ họcDịch tễ học
HọProcess / pipelineProcess / pipeline
Năm ra đời1948 (landmark MRC streptomycin trial)1962 (Kefauver-Harris Amendment formalised phased drug development)
Người khởi xướngAustin Bradford Hill / Medical Research CouncilFDA regulatory framework / ICH guidelines
LoạiExperimental / interventional study designConfirmatory randomised controlled trial
Công trình gốcMedical Research Council (1948). Streptomycin treatment of pulmonary tuberculosis: a Medical Research Council investigation. British Medical Journal, 2(4582), 769–782. link ↗Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385
Tên gọi khácProspective RCT, randomized controlled trial, RCT, controlled clinical trialPhase 3 trial, confirmatory trial, pivotal trial, Phase III RCT
Liên quan56
Tóm tắtA prospective randomized clinical trial (RCT) is an experimental study in which participants are assigned to intervention or control groups by chance before any outcomes are observed, then followed forward in time. Random allocation eliminates systematic selection bias, making this design the gold standard for establishing causal efficacy of treatments in medicine and clinical research.A Phase III clinical trial is a large-scale, confirmatory randomised controlled trial designed to establish the efficacy and safety of an intervention in the target patient population before regulatory submission. It builds on the signal identified in Phase II, tests the intervention at its proposed dose under controlled conditions, and provides the primary evidence base for marketing authorisation or guideline adoption.
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ScholarGateSo sánh phương pháp: Prospective Randomized Clinical Trial · Phase III clinical trial. Truy cập ngày 2026-06-20 từ https://scholargate.app/vi/compare